Face Recognition Task for Facial Disfigurement

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Epilepsy, Diabetes, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the brain adapts to changes in facial appearance, particularly after severe facial disfigurement and facial transplantation. Researchers will use brain imaging to observe how individuals recognize their faces at different stages: before injury, after injury but before transplant, and after receiving a new face. Participants will engage in a face recognition task to assess these changes. The study seeks participants approved for facial transplantation due to severe facial disfigurement who can safely undergo MRI scans. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on facial recognition and brain adaptation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have certain conditions like epilepsy, diabetes, or heart disease, you may be excluded from participating.

What prior data suggests that this face recognition task is safe?

Research has shown that face recognition tasks, like those in this study, are generally safe. These tasks involve viewing different faces, including one's own, to observe brain responses. No reports indicate harmful effects from viewing images or using MRI scans, which reveal brain activity.

The face recognition task does not involve medication or medical procedures. It is non-invasive, meaning it does not physically affect the body, and participants typically manage it well.

However, being in an MRI machine can sometimes be uncomfortable. Participants might feel cramped or hear loud noises, but these are normal experiences with MRI scans and not specific to the face recognition task.

In summary, participating in this study, which examines how the brain processes facial images, is considered safe and unlikely to cause any serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to improving facial recognition in individuals with facial disfigurement, particularly those undergoing facial transplants. Unlike traditional treatments that focus on physical reconstruction, this study uses a face recognition task combined with MRI imaging to understand how the brain processes facial features before and after surgery. This method could offer insights into the neurological aspects of facial recognition, potentially leading to more holistic rehabilitation strategies that integrate both physical and cognitive recovery. By targeting brain activity related to facial recognition, this trial could pave the way for innovative therapies that enhance patients' quality of life beyond just the physical appearance.

What evidence suggests that this face recognition task is effective for facial disfigurement?

Research has shown that face transplants can help people with severe facial injuries regain both function and appearance. This trial will involve participants in a face recognition task at different time points. Studies have found that, over time, patients begin to see their new faces as their own. This change occurs as the brain adjusts to recognizing the new face, observable through a special brain scan called functional MRI. Initially, patients often feel more connected to their pre-injury face, but they gradually begin to accept their new look. Overall, these findings suggest that face transplants can successfully help people recognize and accept their new faces after a serious injury. ^{1 4 6 7 8}

Who Is on the Research Team?

Eduardo Rodriguez

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients with severe facial disfigurement approved for face transplantation. They must be able to undergo MRI scans, give informed consent, and perform the recognition task well. Excluded are those with metal implants, pacemakers, certain medical conditions like epilepsy or heart disease, mental illness history, claustrophobia, or who may be pregnant.

Inclusion Criteria

I have been approved for a facial transplant due to severe disfigurement.

Exclusion Criteria

I do not have epilepsy, diabetes, heart disease, thermoregulatory problems, and I am not pregnant or breastfeeding.

I do not have mental illness, claustrophobia, or neurological conditions that affect MRI quality.

Must be able to enter and be scanned using MRI.

Timeline for a Trial Participant

Pre-Transplant Assessment

Participants are imaged in the MRI scanner to assess brain activity in response to pre-injury and injured facial images.

1-2 weeks

1 visit (in-person)

Post-Transplant Imaging

Participants undergo functional MRI scanning at three points post-transplant to assess changes in brain activity in response to facial recognition.

Approximately 1 year

3 visits (in-person)

Follow-up

Participants are monitored for changes in self-facial recognition and brain activity over time.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Face recognition task

Trial Overview The study uses fMRI to explore brain activity related to self-face recognition after facial transplantation. It aims to pinpoint brain areas involved in recognizing one's own face and track changes over time before injury, post-injury/pre-transplantation, and post-transplantation.

How Is the Trial Designed?

Group I: Post-Transplant Time Point Experimental Treatment 1 Intervention

Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI). Patients for whom a pre-transplant fMRI was obtained will undergo functional MRI scanning at three-points post-transplant (approximately 2 and 4 months +/- 2 months post-operation and again at 1 year +/- 3 months post-transplant).

Group II: Pre-Transplant Time Point Active Control 1 Intervention

Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI)

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2468785525000655

the AI research metrics model (CAARISMA ® ARMM) Face transplantation (FT) offers a reconstructive option for patients with severe facial disfigurements by restoring both function and appearance.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10083597/

The neurocognitive plasticity of self-processing following facial ... We present the first longitudinal investigation of changes in self-face recognition throughout a patient's journey before a life-changing injury.

3. nature.com nature.com/articles/s41598-025-15831-x

Adaptive neural mechanisms of self face recognition after ... Using a self-recognition task with morphed faces, they found stronger identification with the pre-injury face, while recognizing the post-injury ...

4. blogs.kent.ac.uk blogs.kent.ac.uk/psychology/2023/03/28/first-of-its-kind-study-reveals-how-facial-transplant-recipient-recognises-new-appearance-as-their-own/

First of its kind study reveals how facial transplant recipient ... The first ever investigation into how a facial transplant recipient started to accept their new appearance as part of their own identity.

5. researchgate.net researchgate.net/publication/368168693_Facial_Expression_After_Face_Transplant_The_First_International_Face_Transplant_Cohort_Comparison

Facial Expression After Face Transplant: The First ... We report complexity analysis of surface electromyography signals of these two patients in comparison to the results of 10 healthy individuals.

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/25158414241302871

Facial artificial intelligence in ophthalmology and medicine This article aims to elucidate the diverse applications of facial processing tasks, such as facial landmark extraction, face detection, face tracking, facial ...

7. researchgate.net researchgate.net/publication/51702498_Clinical_outcomes_of_facial_transplantation_A_review

Clinical outcomes of facial transplantation: A review Complications of immunosuppression and patient mortality have been observed in the initial series. These have highlighted rigorous patient ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20679828/

Utility scores for facial disfigurement requiring ... ... face transplant procedure with a 34 percent chance of death ... Utility scores for facial disfigurement requiring facial transplantation [outcomes article].